WO2014170782A1 - Conception de lumiere optimale pour dispositif de detection de forme optique - Google Patents

Conception de lumiere optimale pour dispositif de detection de forme optique Download PDF

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Publication number
WO2014170782A1
WO2014170782A1 PCT/IB2014/060345 IB2014060345W WO2014170782A1 WO 2014170782 A1 WO2014170782 A1 WO 2014170782A1 IB 2014060345 W IB2014060345 W IB 2014060345W WO 2014170782 A1 WO2014170782 A1 WO 2014170782A1
Authority
WO
WIPO (PCT)
Prior art keywords
optical fiber
lumen
elongated device
areas
optical
Prior art date
Application number
PCT/IB2014/060345
Other languages
English (en)
Inventor
Franciscus Reinier Antonius VAN DER LINDE
Bharat RAMACHANDRAN
Martinus Bernardus Van Der Mark
Original Assignee
Koninklijke Philips N.V.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Koninklijke Philips N.V. filed Critical Koninklijke Philips N.V.
Publication of WO2014170782A1 publication Critical patent/WO2014170782A1/fr

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Classifications

    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B23/00—Telescopes, e.g. binoculars; Periscopes; Instruments for viewing the inside of hollow bodies; Viewfinders; Optical aiming or sighting devices
    • G02B23/24—Instruments or systems for viewing the inside of hollow bodies, e.g. fibrescopes
    • G02B23/2476—Non-optical details, e.g. housings, mountings, supports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2061—Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Definitions

  • the present invention relates to the field of elongated devices, especially steerable elongated devices with optical shape sensing capability.
  • optical shape sensing By using optical shape sensing, the shape of an elongated steerable medical device can be reconstructed by integration of an optical fiber in such a device. This is possible by calculating strains along a multicore optical fiber.
  • Such optical shape sensing has a number of medical applications since it allows important navigational guidance for elongated interventional medical devices. Such devices can be used for example within medical applications in the form of diagnostic devices, e.g. catheters, guide wires, endoscopes, stylets or needles, and treatment devices, e.g. ablation devices.
  • the invention provides an elongated device comprising a longitudinal portion comprising a lumen arranged for housing an optical fiber, wherein the lumen has a shape comprising at least first and second areas in which the optical fiber can be positioned, and wherein said first and second areas are connected by a channel shaped to allow the optical fiber to move between the first and second areas.
  • Such device is advantageous, since it allows use of an elastomeric material for the longitudinal portion of the elongated device in which the lumen is formed, without the use of a special reinforcing material, e.g. High Density Poly-Ethylene (HDPE), Polyamide (PA) or metal or the like, keeping the elongated device flexible which is needed for certain application that desire flexible elongated devices.
  • the dual lumen design with two main areas connected by a rather narrow channel, e.g. a lumen with a dumbbell shape, allows a solution to stick-slip and bending problems without requiring a significant cross sectional space for the optical shape sensing functionality. With such dual lumen design, the optical fiber is allowed to have a free space to maneuver to passively in any situation or orientation of the elongated device, without suffering from tension, twist or pinching that could influence the shape reconstruction negatively.
  • the lumen is preferably shaped to act to provide a bi-stable positioning of the optical fiber: the channels are preferably designed to force the optical fiber to either move to the first area or to the second area, when the elongated device is bent.
  • the channel can be so narrow at its most narrow point, that it is only slightly larger than the cross sectional area of the optical fiber, while the first and second areas of the lumen offer more space to the optical fiber to allow it to freely move.
  • the dual lumen design allows the lumen to occupy only a limited cross sectional area of the elongated device, without the need for stiffening or reinforcing material to be integrated for protection of lumen integrity in the otherwise elastic material, i.e. thermoplastic elastomers that are typically used for flexible elongated devices around the lumen.
  • a shape of the lumen is considered when the longitudinal portion of the elongated is in a straight position without bending.
  • the lumen is formed inside an elastic material, polymer or the like, which will be compressed upon bending, and thus the shape of the lumen will change in response to such bending.
  • the channel part is so narrow, that bending will cause the channel to be compressed so much that the optical fiber cannot pass the channel, but in that case the purpose is that the optical fiber will then be positioned in one of the first and second areas, which are preferably of larger dimensions than the channel, and further placed at different parts of the cross sectional area, such that the optical fiber will have free space in at least one of the first and second areas without getting stuck.
  • the channel is shaped so as to force the optical fiber to move towards one of the first and second areas upon bending of said longitudinal portion of the elongated device.
  • the lumen acts as a dual lumen causing the optical fiber to move towards one of the first and second lumen areas. This can be achieved e.g. by a curved channel with a top point with a minimal width of the channel midway between the first and second areas.
  • the lumen can be symmetric with the first and second areas having the same geometry and placed at respective ends of a symmetric channel.
  • the lumen may be dumbbell shaped.
  • the channel is preferably shaped to provide a gradual and smooth transition between the first and second areas. This helps to provide the effect that the optical fiber is forced to move towards the nearest one of the first and second areas without being stuck in the channel part of the lumen.
  • a smallest dimension of the channel is smaller than a smallest dimension of the first and second areas.
  • only a limited lumen area is used for the channel part, while a significant part of the total lumen area is used in the first and second areas, where the optical fiber preferably has space to move freely.
  • the first and second areas preferably have a curved shape, to ensure that the optical fiber will not be trapped by edges or the like.
  • the lumen may be positioned symmetrically or asymmetrically relative to a central axis of said longitudinal portion.
  • An asymmetrically placed dual lumen for the optical fiber has some advantages with respect to shape sensing reconstruction.
  • the lumen may be positioned in a peripheral part of a cross sectional area of said longitudinal portion of the elongated device.
  • the lumen may be shaped such, and positioned such in relation to a cross sectional area of said longitudinal portion of the elongated device, that the first and second areas are positioned on each side of the cross sectional area of said longitudinal portion.
  • said longitudinal portion comprises a second lumen arranged for housing a component related to a function of the elongated device.
  • a circular lumen separate from the lumen for the optical fiber is provided for a guide wire, catheter, cable or the like, related to the function of the elongated device.
  • the lumen may be formed inside an elastic material, such as an elastic material known to be used within steerable elongated devices.
  • an elastic material such as an elastic material known to be used within steerable elongated devices.
  • TPE Thermoplastic Elastomers
  • the lumen may be formed inside an elastic material with a first elasticity, and wherein another part of a cross sectional area of said longitudinal portion is formed by a material with a lower elasticity.
  • a stiffer material can be used for the cross sectional part accommodating a lumen for a guidewire, a catheter or the like.
  • the two materials with different elasticity may be two different types of materials.
  • the elongated device comprises an optical fiber arranged within said lumen, and wherein the optical fiber is arranged for sensing a shape of the elongated device, upon use of the elongated device.
  • the elongated device may especially be an interventional medical device.
  • the elongated device can be applied in a variety of other applications than medical applications.
  • said longitudinal portion is position at a distal end of the elongated device.
  • the tip end of the elongated device is specially suited to allow bending and still provide high quality optical shape sensing.
  • the elongated device may comprise a plurality of said longitudinal portions with a dual lumen for housing the optical fiber, separated by longitudinal portions with a single lumen, i.e. a prior art lumen, for housing the optical fiber.
  • the entire elongated device may have a lumen as the defined in the first aspect.
  • said longitudinal portion is within a lasso shaped part of the elongated device.
  • such lasso shaped part of the elongated device may form the tip part of the elongated device, e.g. such lasso shaped tip part is known for circular mapping, e.g. for arteries.
  • the first and second areas are shaped such in relation to the size of the optical fiber, that a smallest dimension of the first and second areas is at least a factor of 1.2 of a diameter of the optical fiber.
  • a factor is larger, e.g. at least 1.5, such as at least 2.0.
  • the lumen may have more than two areas connected by one channel.
  • three main areas can be connected by two channels, or connected in a ring by three channels.
  • Even further combinations of main areas for the optical fiber interconnected by channels can be designed.
  • the invention provides an optical shape sensing system comprising an optical fiber, an elongated device according to the first aspect, and an optical console arranged for connection to the optical fiber, wherein the optical console is arranged to transmit an optical signal to the optical fiber, and to generate an indication of a shape of the elongated device in response to an optical response received from the optical fiber.
  • the invention provides use of the elongated device according to the first aspect for optical shape sensing. Especially, such use is preferable for medical applications.
  • the third aspect provides a method for optical shape sensing comprising providing an elongated device according to the first aspect, and connecting the optical fiber therein to a system capable of sensing a shape of the optical fiber within the elongated device.
  • the third aspect provides a method for optical shape sensing, such as in a medical application, by providing the system according to the second aspect.
  • Fig. 3 illustrates cross section of an embodiment with an asymmetrically placed lumen for housing an optical fiber
  • Figs. 4a and 4b illustrate cross sections of an embodiment made of two materials with different elastic properties
  • Fig. 6 shows steps of a method embodiment.
  • the catheter C is straight, and as seen, the catheter C has a circular cross section, and the lumen LM is circular as well, and sized slightly larger than a diameter of the likewise circular optical fiber to allow the optical fiber to move freely.
  • Figs. 2a and 2b illustrates examples of a dual lumen design according to the invention, in the form of cross sections of a longitudinal portion of an elongated device embodiment.
  • Fig. 2a shows the cross section when the longitudinal portion is in a straight position
  • Fig. 2b illustrates the cross section with the longitudinal portion in a bent position.
  • Fig. 2a shows the lumen LM design where the surrounding elastic material EM is in a non-compressed situation.
  • the two areas LI, L2 are sized to ensure that the optical fiber OF can move freely, even when the elongated device is in a compressed situation.
  • the extra separate circular lumen L A in the elastic material EM serves the purpose of providing space for a guide wire, cable, catheter, cannula or the like, according to the function of the elongated device in question.
  • the smallest dimension available for passage of the optical fiber OF in the channel CH is smaller than the smallest dimension available in the first and second areas LI, L2.
  • the lumen LM is symmetric, and it is positioned symmetrically in relation to a central axis along the elongated device.
  • the channel CH preferably has a spacing in the middle of the channel CH that is smaller than towards either two of the areas LI, L2. This transition in increasing distance is preferably gradual, so as to provide a smooth path for the optical fiber OF, since this will ensure that the optical fiber OF will redirect itself in either one of the two lumens when the space in the channel will decrease and is insufficient for the optical fiber to move freely. In this way, pinching of the OSS fiber will not occur and the OSS fiber can move freely longitudinally and rotationally.
  • both lumen areas LI, L2 may be oriented as close as possible to the symmetry axis to keep the deformation at these places to a minimum.
  • the lumen LM is positioned asymmetrically in relation to a central axis of the elongated device.
  • the registration can be updated and at no point, the optical fiber OF measurement can be seen outside the instrument or anatomy in the resulting shape sensing image, while still having the advantages explained in the previous embodiment.
  • the lumen LM shape in combination with the elastic properties of the material EMI surrounding it, may be selected such that the channel part CH is expected to be compressed entirely, or at least to a degree such that the optical fiber OF cannot pass the channel CH, as it is also indicated in Fig. 4b, thereby forcing the optical fiber OF to remain in one of the main areas LI, L2.
  • the elongated device can have the different polymers of different durometers over its entire longitudinal length, or it can be only at the proximal part, or it can be only at the distal part of the elongated medical device.
  • the described principle of different elastic material properties could be extended to include three, four, or even more different materials in respective areas of the cross sectional areas which could have different elastic properties with the purpose of controlling the compression of the respective areas upon bending of the elongated device.
  • Fig. 5 shows an optical shape sensing system with an elongated device with two different longitudinal portions: a first longitudinal portion LPl at the proximal end, and a second longitudinal portion LP2 at the distal end.
  • the first longitudinal portion LPl may have a conventional lumen design for housing an optical shape sensing fiber, while the optical fiber is housed within a second longitudinal portion LP2 having a lumen design according to the invention, thereby allowing the distal end to bend without severe distortion of the reconstructed shape.
  • the distal end of the second longitudinal portion LP2 may be lasso shaped.
  • the optical shape sensing fiber in the elongated device is optically connected to an optical console OC forming part of an optical shape sensing device OSS.
  • the optical console OC generates an output to a display to allow visualization of the reconstructed shape of the elongated device, e.g. for use as navigational guidance in case of the elongated device being a steerable medical interventional instrument.
  • only longitudinal sub-sections or portions of the elongated device may have lumens according to the invention, while the remainder of the elongated device can have a conventional single lumen design.
  • instruments used for different procedures, and these come with different constraints, shapes and curvatures. These parameters can be optimized in order to determine the kinds of lumen and sub-section that has dual or multiple lumens.
  • a Lasso catheter used during electrophysiology has a circle with tight radius of curvature at the distal portion. Due to this shape, this portion will undergo more ovalization and having a lumen according to the invention will allow stable shape sensing without causing stick-slip and pinch points.
  • the non-reinforced lumen design according to the invention can be optimized per instrument by using optical shape sensing data.
  • optical shape sensing also provides the twist and axial tension information.
  • optical shape sensing can collect data on longitudinal and rotational stick-slip. Knowing this information and conducting bench top tests, the dimensions of the design can be optimized per procedure and per type of device, such that the optical fiber can slide irrespective of the kind of ovalization.
  • Movement of the optical fiber can be improved by adding a coating or liquid to either the optical fiber or the inside of the lumens and channel to decrease the friction coefficient to improve the movement of the optical fiber.
  • the latter can also be covered by a solid material like PTFE to reduce the friction coefficient.
  • the lumen design can be made with extrusion. Making a die that is the inverse of the eventual design will give open structures (lumens) at places where material is present in the die. Creating different kinds of dies is standard practice in extrusion processes.
  • Fig. 6 illustrates steps of a method embodiment.
  • an elongated device with an optical fiber according to the first aspect is provided, P ED.
  • An optical signal is applied to the optical fiber, A OS.
  • An optical response from the optical fiber to the optical signal is sensed, S_R, and accordingly, a shape is computed, C_S.
  • the computed shape is displayed, D_S.
  • the lumen design according to the first aspect of the invention a reliable shape sensing can be obtained even when the elongated device is bent and turned.
  • the method may be used as navigational guidance in a medical application, however a number of other application areas exist.
  • the invention provides an elongated device having a longitudinal portion with a lumen arranged for housing an optical fiber.
  • the lumen has a shape with at least two main areas, thus effectively creating a dual lumen, in which the optical fiber can be positioned, and a channel connects the two main areas, such that the optical fiber can move between the first and second areas.
  • the lumen can be dumbbell shaped.
  • the two main areas and the channel are shaped such that the optical fiber is forced towards one of the main areas upon bending of the elongated device, thus avoiding stick-slip and tension problems when the optical fiber is getting stuck. This improves quality of shape
  • the invention is advantageous for steerable medical elongated devices where optical shape sensing is used for navigational guidance.

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  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Optics & Photonics (AREA)
  • General Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Astronomy & Astrophysics (AREA)
  • Human Computer Interaction (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un dispositif allongé ayant une partie longitudinale comprenant une lumière conçue pour recevoir une fibre optique. La lumière présente une forme ayant au moins deux régions principales, créant ainsi efficacement deux lumières, dans lesquelles la fibre optique peut être positionnée, et un canal relie les deux régions principales de telle sorte que la fibre optique peut se déplacer entre les première et seconde régions. Par exemple, la lumière peut avoir une forme d'haltère. De préférence, les deux régions principales et le canal sont formés de telle sorte que la fibre optique est forcée vers l'une des régions principales lors de la courbure du dispositif allongé, évitant ainsi des problèmes de glissement saccadé et de tension lorsque la fibre optique est coincée. Cela améliore la qualité de reconstruction de forme lorsque la fibre optique est utilisée pour une détection de forme optique, et une structure de renforcement dans le dispositif allongé peut être évitée, permettant ainsi au dispositif d'être mince. Ainsi, l'invention est avantageuse pour des dispositifs allongés médicaux orientables dans lesquels une détection de forme optique est utilisée pour un guidage de navigation.
PCT/IB2014/060345 2013-04-18 2014-04-01 Conception de lumiere optimale pour dispositif de detection de forme optique WO2014170782A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361813228P 2013-04-18 2013-04-18
US61/813,228 2013-04-18

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WO2014170782A1 true WO2014170782A1 (fr) 2014-10-23

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111405864A (zh) * 2017-09-28 2020-07-10 皇家飞利浦有限公司 光学连接设备和方法
EP3668581A4 (fr) * 2017-11-28 2021-05-19 St. Jude Medical, Cardiology Division, Inc. Cathéter de gestion de lumière

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060009740A1 (en) * 2001-08-28 2006-01-12 Michael Higgins Multiple lumen catheter having a soft tip
US20080064927A1 (en) * 2006-06-13 2008-03-13 Intuitive Surgical, Inc. Minimally invasrive surgery guide tube
WO2011100124A1 (fr) * 2010-02-12 2011-08-18 Intuitive Surgical Operations, Inc. Méthode et système pour obtenir des mesures tridimensionnelles absolues à l'aide d'un capteur de forme insensible à la torsion
US20120327392A1 (en) * 2006-03-22 2012-12-27 Koninklijke Philips Electronics N.V. System and method for sensing shape of elongated instrument

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060009740A1 (en) * 2001-08-28 2006-01-12 Michael Higgins Multiple lumen catheter having a soft tip
US20120327392A1 (en) * 2006-03-22 2012-12-27 Koninklijke Philips Electronics N.V. System and method for sensing shape of elongated instrument
US20080064927A1 (en) * 2006-06-13 2008-03-13 Intuitive Surgical, Inc. Minimally invasrive surgery guide tube
WO2011100124A1 (fr) * 2010-02-12 2011-08-18 Intuitive Surgical Operations, Inc. Méthode et système pour obtenir des mesures tridimensionnelles absolues à l'aide d'un capteur de forme insensible à la torsion

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111405864A (zh) * 2017-09-28 2020-07-10 皇家飞利浦有限公司 光学连接设备和方法
CN111405864B (zh) * 2017-09-28 2023-08-29 皇家飞利浦有限公司 光学连接设备和方法
EP3668581A4 (fr) * 2017-11-28 2021-05-19 St. Jude Medical, Cardiology Division, Inc. Cathéter de gestion de lumière
EP4115936A1 (fr) * 2017-11-28 2023-01-11 St. Jude Medical, Cardiology Division, Inc. Cathéter de gestion de lumen
US11672947B2 (en) 2017-11-28 2023-06-13 St. Jude Medical, Cardiology Division, Inc. Lumen management catheter
EP4327771A3 (fr) * 2017-11-28 2024-05-29 St. Jude Medical, Cardiology Division, Inc. Cathéter de gestion de lumière

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